Basic Info.

HS Code

9027809990

HS Code

9027809990

Product Desciption

POCT HbA1c Analyzer-------LD-100

INTENDED USE
This instrument is intended for the percent determination of hemoglobin A1c (HbA1c) in human whole blood.

PRINCIPLE
HbA1c Analyzer uses the (borate affinity) fluorescent immunoturbidimetry. Push a mixture containing a fluorescent borate conjugate into an integrated test cup and mix to dissolve sufficiently. The blood samples in the sample collector are then pushed into the buffer and mixed to release the hemoglobin from the red blood cells.

Performance Parameters
 Accuracy:The accuracy is tested with the reference material as samples, and the relative deviation of the determination results of the analyzer should be within the range of ±8%.
Precision:Samples with a concentration of 4.0%-6.5% are detected, and the sample coefficient of variation (CV) of the test results is not more than 3%.
Linearity:In the range of 4%-16% of HbA1c, the linear correlation coefficient r of the test results should be no less than 0.9900.
Stability:Within 8 hours after the instrument is turned on and stable, the same normal sample is tested, and the relative deviation of the test results is not more than ±3%. 

CERTIFICATE



COMPANY INFORMATION
LABNOVATION TECHNOLOGOES, INC was established in 2001 and has been recognized as a "National High-tech Enterprise". The registered capital (including its wholly-owned subsidiaries) is RMB 20 million, and it is one of the earliest companies exporting in vitro diagnostic reagents in China. The product sales network has covered more than 110 countries and regions around the world.
It is the first in the industry to pass the ISO9001:2008.ISO13485:2012/AC:2012 quality system TUV certification, and obtain the EU CE certification and FDA certification.
The company invests more than 10% of its sales into product research and development, hardware construction and update every year, and 85% of the company's R&D team employees have more than 5 years of industry experience.